Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2018 - (Recall #: Z-1250-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

Product Classification:

Class II

Date Initiated: November 9, 2017

Date Posted: April 4, 2018

Recall Number: Z-1250-2018

Event ID: 79418

Reason for Recall:

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Status: Terminated

Product Quantity: 1244

Code Information:

1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259

Distribution Pattern:

Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated